Assyro AI

Orange Book product · Generic (ANDA)

TIOTROPIUM BROMIDE

TIOTROPIUM BROMIDE

Generic (ANDA)ANDA 211287TE ABRX LUPIN

At a glance

Jun 20, 2023

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 20, 2023

    3 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

TIOTROPIUM BROMIDE

Strength

EQ 0.018MG BASE/INH

Dosage form

POWDER

Route

INHALATION

TE code

AB

Application

ANDA 211287

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of TIOTROPIUM BROMIDE

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.